Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
David Nettleton
75 Mins
Product Id: 701582
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
Supplier Management with the new Medical Device Regulation EU MDR 745/2017
Frank Stein
60 Mins
Product Id: 706068
In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body.
Latest Changes to RoHS and REACH for 2026
Kelly Eisenhardt
60 Mins
Product Id: 706070
This 1-hour webinar will go into the specifics of the REACH and RoHS regulations and review the latest amendments and changes to both regulations for 2026. We will draw out key developments and key dates (if applicable) with particular emphasis on requirements for US firms.
Elements of an Effective Change Control System
Michael Ferrante
60 Mins
Product Id: 703345
This webinar will focus on the regulatory and design requirements for an effective change control system in the pharmaceutical industry. Attendees will learn the role and importance of change control system in implementing an effective quality system.
Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)
Barry A Friedman
90 Mins
Product Id: 705433
The webinar will review the current testing requirements as defined in the new, revised FDA guidance on Endotoxin and Pyrogen testing. It will further help attendees understand the issues surrounding the Low Endotoxin Recovery (LER) and its regulatory outcome.
How to identify and investigate Financial Crimes Red flags
Justin Muscolino
60 Mins
Product Id: 707032
When it comes to AML, there are a lot of different components. For staff it's really important to not only know how the rules impact their role, but understanding the different types of red flags. In this webinar, we will discuss the background of AML and also the types of red flags you may encounter during your day to day roles.
Aseptic Processing Overview and Validation
Kelly Thomas
90 Mins
Product Id: 706212
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.
NEW Reclamation Process - Fed Gov't Payments
Donna K Olheiser
90 Mins
Product Id: 706928
Processing ACH Reclamations from the Federal Government can be challenging! Chapter 5 of the Green Book has been updated making it mandatory for Financial Institutions to respond to all reclamations must be submitted through the Automated Reclamation Processing System (ARPS) located in Treasury’s Pay.gov web portal (except for responses by DFAS and any Treasury-approved exceptions). The Nacha Operating Rules still apply when processing these payments but the Green Book outlines exceptions when handling DNEs (Death Notification Entries) and Federal Government Reclamations. A side-by-side comparison of Commercial vs. Government Reclamations will be included to know what the difference is and how to handle each one.
The Safety Responsibility of the HR Manager | HR and OSHA Laws
Michael Aust
60 Mins
Product Id: 704831
This webinar will explain legislative roles and responsibilities of workplace parties and how HR plays a pertinent role in it. Instructor will discuss OSHA regulations and safety compliance practices and how to create safety culture at workplace. He will share practical tips and best practices for HR managers taking the responsibility of safety regulatory compliance.
Toxic Substance Control Act (TSCA) Awareness Training 101
Joe Keenan
90 mins
Product Id: 706205
Attend this training to understand all the requirements of the Toxic Substance Control Act (TSCA), its revisions, and how to develop a written plan, TSCA Training Plan. Get answers to your TSCA questions.
The Importance of Packaging and Labeling in Pharmaceutical Product Development
Michael Esposito
60 Mins
Product Id: 706063
Packaging and labeling is often underestimated in the planning phases of pharmaceutical product development. This leads to unnecessary increases in cycle time, costly errors, and delays in product availability, or product recalls due to noncompliance. This webinar will help you succeed in pharmaceutical product launch by exploring its importance right from the conception of a product, its realization and distribution.
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
David Nettleton
90 Mins
Product Id: 701687
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
You have a BI Positive or Product Sterility Positive - Now What?
Gerry O Dell
75 Mins
Product Id: 703288
This webinar explains what actions should be taken following an unexpected positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It also addresses the actions to take when a test of sterility demonstrates unexpected growth during validation or routine dose audits. The various items that should be investigated to determine the root cause and the follow up to the investigation will be covered.
Social Media Compliance for Fair Lending: What to post and what not to
Justin Muscolino
60 Min
Product Id: 706987
Ensure compliance in your social media marketing efforts with our "Social Media Compliance for Fair Lending" training. Learn what content is permissible and what's not to avoid potential regulatory issues. This course covers guidelines for posting on various social media platforms while adhering to fair lending laws. Gain insights into creating compliant content that promotes transparency and fairness in your lending practices. Equip your team with the knowledge needed to navigate the complexities of social media compliance, mitigate risks, and maintain regulatory adherence in your digital marketing strategies.
Human Error Investigations, Root Cause Determination and CAPA Effectiveness
Ginette M Collazo
90 Mins
Product Id: 704314
This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.
Current Trends in FDA Inspections
Michael Ferrante
90 Mins
Product Id: 703485
This webinar will focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.
Process Simulation Testing for Aseptically Filled Products; An In-depth Examination of the Latest Product Sterility Assurance Levels Prescribed by GMPs
Barry A Friedman
90 Mins
Product Id: 706882
The objective of this live, interactive training webinar is to explore the role of media fills in assuring that manufactured product will retain the sterility assurance level prescribed by GMPs. It will review the issues regarding preparing media and setting up the “filtration train”, environmental monitoring, interruptions that may occur during the operation of the Clean Room (planned and unplanned) and the cleaning of the room and its equipment. Equipment used to monitor the equipment and personnel will also be reviewed along with gowning issues that periodically arise. The webinar will also discuss media failures and how to “work through” them. Because of the sensitivity and importance of media fills, this live, interactive training webinar is a MUST for anyone in your organization that is involved in aseptic filling in general and media fills, in particular.
FDA Guidance for Use of Social Media by Regulated Industries
Carolyn Troiano
90 Mins
Product Id: 707033
This webinar training will help you understand in detail the application of FDA’s draft guidance documents on the use of social media in presenting and promoting information about drug products and medical devices subject to FDA regulation. This is critical in order to develop the appropriate strategy, policies, and procedures to ensure compliance.
Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals
Kelly Eisenhardt
60 Mins
Product Id: 703871
This training program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and policies needed to implement them.
Unauthorized Transactions – Reg E vs Nacha Operating Rules
Donna K Olheiser
90 Mins
Product Id: 706856
Unauthorized transactions come in many different forms, when returning using Reg E or the Nacha Operating Rules can be confusing. Discussion will include what, why and when while processing unauthorized returns. The trainer will define the limits of liability and who is liable for what amount while providing some real-life scenarios. Details on the error resolution process with Reg E for consumer notification to the financial institution, research time involved, and the timing of providing provisional credit; included will be guidelines on the “what if” there is no error, and providing notice to consumer, and any overdraft protection relating to that provisional credit being reversed. Included will be outlining the ACH return process, when using the ACH network is appropriate, and paperwork/forms needed. Recent Rules changes affecting Nacha compliance when sending unauthorized ACH Returns using Return Reason Codes R10 vs. R11 is included.







